Pfizer Pill Leads Race to Dominate $12 Billion Market

Pfizer is counting on revenue from tasocitinib to help offset losses when its top-selling Lipitor cholesterol pill, seen here, faces competition next year from cheaper copies in the U.S. Photographer: JB Reed/Bloomberg

Nov. 5 (Bloomberg) -- Pfizer Inc., the world’s biggest
drugmaker, leads a race against three rivals to sell the first
new pill in a decade for rheumatoid arthritis, a joint disease
treated by injected drugs with $12 billion in annual sales.

The tablet, called tasocitinib, curbed inflammation and
stopped the disease from worsening, Pfizer reported last week.
Pfizer may edge out shots sold by Johnson & Johnson, Abbott
Laboratories, and Amgen Inc. if research to be presented Nov. 10
at the American College of Rheumatology in Atlanta suggests its
tablet is also a safe alternative.

Tasocitinib is the most advanced pill in a family of
experimental drugs to target a protein, called JAK, which leads
to joint destruction in 1.3 million Americans with rheumatoid
arthritis. Pfizer’s study is the first late-stage JAK trial, one
of six the company plans to complete by the end of next year.
The pill can generate peak annual sales of $2 billion, said Tim
Anderson, an analyst with Sanford C. Bernstein & Co.

“Tasocitinib’s main value proposition is that it is a
first-in-class novel oral therapy launching into an area filled
with injectable products that collectively sell about $12
billion a year for rheumatoid arthritis alone,” Anderson said
in a Nov. 1 research report.

Pfizer shares fell 20 cents, or 1.2 percent, to $17.18 at 4
p.m. in New York Stock Exchange composite trading. The New York-based drugmaker rose less than a percent in the 12 months
through today.

Lipitor Competition

Pfizer is counting on revenue from tasocitinib to help
offset losses when its top-selling Lipitor cholesterol pill,
with $11.4 billion in annual sales, faces competition next year
from cheaper copies in the U.S. The company gained the arthritis
remedy Enbrel in last year’s $68 billion purchase of Wyeth. The
anti-inflammatory medicine generated $799 million in the third
quarter, making up 5 percent of Pfizer’s revenue.

Rheumatoid arthritis is a chronic disease where the immune
system mistakenly attacks healthy tissue, causing inflammation
in and around joints. Shots known as anti-TNF therapy are
standard care for the 80 percent of patients who don’t respond
to treatment with methotrexate, a generic drug that can block
cell growth in people with certain cancers and immune disorders.

Three biotechnology companies are trying to catch up to
Pfizer with their own JAK drugs - Rigel Pharmaceuticals Inc.,
Incyte Corp., and Vertex Pharmaceuticals Inc. Pfizer’s pill is
the only one in the third and final stage of tests generally
needed for U.S. approval.

Two-Year Lead

Tasocitinib “appears to be in the lead by at least two
years in comparison to other JAK inhibitors,” said Marc
Goodman, an analyst with UBS Securities, in an Oct. 27 note to
clients. “We believe that the safety issues are key to gaining
the appropriate label and could limit its use to patients with
low cardiovascular risk.”

Investors are most concerned about whether Pfizer’s drug
will raise cholesterol levels enough to limit the number of
patients who might use it, Goodman said. The pill showed signs
of this side effect in previous study results.

Doctors may be slow to adopt new JAK drugs for patients who
are already getting relief from older treatments, said David
Pisetsky, professor of rheumatology and immunology at Duke
University School of Medicine. While high cholesterol linked to
tasocitinib may be treatable, physicians may resist adding an
additional drug to patients’ daily treatment regimens.

“Because it’s a new mode of action, there’s great
interest, but what’s going to happen in terms of efficacy and
safety when you really put it out there?” Pisetsky said in a
telephone interview. “There’s always a difference between what
happens in a trial setting and what happens in real life.”

Enbrel, Remicade

The rheumatoid arthritis market is dominated by three anti-TNF treatments: Enbrel from Pfizer and Thousand Oaks,
California-based Amgen; Humira, from Abbott Park, Illinois-based
Abbott; and Remicade, sold by New Brunswick, New Jersey-based
J&J and Merck & Co., based in Whitehouse Station, New Jersey.
The treatments cost as much as $20,000 a year and leave patients
susceptible to infections.

Summary results of the first three months of Pfizer’s six-month study were released last week. The study’s 611 patients
took one of two doses of the drug or a placebo pill. After three
months of treatment, 66 percent of patients taking the higher
dose had at least a 20 percent improvement of symptoms, compared
with 27 percent in the placebo group. Side effects were reported
by 330 patients, with 25 seriously affected. Thirteen patients
stopped taking the drug. A 79-year-old woman with a history of
heart disease and diabetes died after developing diarrhea
followed by renal failure.

Complete Data

The complete six-month data from the trial will be released
Nov. 7 and presented Nov. 10 at the rheumatology meeting. The
presentation will include the number of patients with 70 percent
improvement and will describe side effects in greater detail.

Incyte Corp., based in Wilmington, Delaware, will present
the second of three stages of testing of its drug, INCB-28050,
at the rheumatology meeting. Early results of the 125-patient
trial show similar effectiveness to Pfizer’s drug and comparable
anti-TNFs, though more studies are needed, said Goodman of UBS.
Incyte is partnered with Eli Lilly & Co., of Indianapolis.

Rigel, of South San Francisco, California, in September
entered late-stage research for its JAK drug, called
fostamatinib, in joint development with London-based AstraZeneca
Plc. A study in July 2009 failed to show statistically
significant improvement for patients taking the drug.

Vertex, based in Cambridge, Massachusetts, is conducting a
mid-stage trial of its JAK drug, VX-509.

Methotrexate, now generic, was approved in 1988 and sells
for less than $1 a pill. Arava, a pill approved in 1998 for
Paris-based Sanofi-Aventis SA, is also sold as a generic.